US Compounding Recalls Betamethasone Vials Due to Sterility Concerns
US Compounding Inc is recalling 5,514 vials of Betamethasone Combo PF 2 mL due to deficient practices that may impact sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a sterile injection product where sterility assurance is compromised is categorized as Severe (Score 4) due to the significant risk of infection or injury.
Plain-English summary
US Compounding Inc is recalling 5,514 vials of Betamethasone Combo PF 2 mL (6 mg/mL) 10 mL Multi-Dose Vial. The product is a prescription-only medication intended for intramuscular and regional injection, compounded by US Compounding Pharmacy in Conway, Arkansas. The recall is nationwide.
The recall was initiated due to a lack of assurance of sterility. The firm identified deficient practices that may have an impact on sterility assurance for all sterile preparations within their expiry dates. Specific lot numbers and beyond-use dates are listed in the recall documentation.
Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or pharmacist for further instructions. The recall covers specific lots with beyond-use dates ranging from September 2015 to January 2016.
The recalled product
- Product
- Betamethasone Combo PF 2 mL (6 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-02
- Manufacturer
- US Compounding Inc
- Category
- Drug — Sterile Injectable
- Affected units
- 5,514
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Numbers: 20150206@41 BUD: 11/28/2015
- 20151603@58 BUD: 9/12/2015
- 20152007@43 BUD: 1/16/2016
- 20152104@41 BUD: 10/18/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by US Compounding Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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